title: Whole brain helical Tomotherapy with integrated boost for brain metastases in patients with malignant melanoma-a randomized trial.
abstract: BACKGROUND
  Patients with malignant melanoma may develop brain metastases during the course of the disease, requiring radiotherapeutic treatment. In patients with 1-3 brain metastases, radiosurgery has been established as a treatment option besides surgery. For patients with 4 or more brain metastases, whole brain radiotherapy is considered the standard treatment. In certain patients with brain metastases, radiation treatment using whole brain helical Tomotherapy with integrated boost and hippocampal-sparing may improve prognosis of these patients.
  
  
  METHODS
  The present prospective, randomized two-armed trial aims to exploratory investigate the treatment response to conventional whole brain radiotherapy applying 30 Gy in 10 fractions versus whole brain helical Tomotherapy applying 30 Gy in 10 fractions with an integrated boost of 50 Gy to the brain metastases as well as hippocampal-sparing in patients with brain metastases from malignant melanoma. The main inclusion criteria include magnetic resonance imaging confirmed brain metastases from a histopathologically confirmed malignant melanoma in patients with a minimum age of 18 years. The main exclusion criteria include a previous radiotherapy of the brain and not having recovered from acute high-grade toxicities of prior therapies. The primary endpoint is treatment-related toxicity. Secondary endpoints include imaging response, local and loco-regional progression-free survival, overall survival and quality of life.
  
  
  BACKGROUND
  http://www.drks.de Trial ID: DRKS00005127.
authors.affiliation: Department of Radiation Oncology, University Hospital of Heidelberg, INF 400, 69120, Heidelberg, Germany. Henrik.Hauswald@med.uni-heidelberg.de.
authors.forename: Henrik
authors.initials: H
authors.lastname: Hauswald
authors.forename: Gregor
authors.initials: G
authors.lastname: Habl
authors.forename: David
authors.initials: D
authors.lastname: Krug
authors.forename: Denise
authors.initials: D
authors.lastname: Kehle
authors.forename: Stephanie E
authors.initials: SE
authors.lastname: Combs
authors.forename: Justo Lorenzo
authors.initials: JL
authors.lastname: Bermejo
authors.forename: Jürgen
authors.initials: J
authors.lastname: Debus
authors.forename: Florian
authors.initials: F
authors.lastname: Sterzing
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001932:Brain Neoplasms / Q000532:radiotherapy* / Q000556:secondary*; D016371:Cranial Irradiation / Q000379:methods*; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000556:secondary*; D008875:Middle Aged; D011879:Radiotherapy Dosage; D011880:Radiotherapy Planning, Computer-Assisted; D050397:Radiotherapy, Intensity-Modulated / Q000379:methods*; D012107:Research Design; D055815:Young Adult